Safety Alert for Diagnostic Imaging System

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Volcano Corporation.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
  • Event Number
  • Date
  • Event Country
  • Event Source
  • Event Source URL
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Colombia.
  • Extra notes in the data


  • Model / Serial
    S5 / SI software versions 3.3 and 3.4
  • Product Description
    The VOLCANO system is used for the qualitative and quantitative evaluation of the vascular morphology in the coronary arteries and vessels of the peripheral vasculature. They are also indicated as a complement to conventional angiographic procedures to provide an image of the vessel lumen and option wall structures. CHROMAFLO is indicated for qualitative information about the blood flow of the coronary and peripheral vasculature; this information can complement other methods used to estimate perfusion and blood flow. The VH IVUS system is intended to be used in conjunction with imaging catheters during ultrasound imaging of the peripheral and coronary vasculature. The VOLCANO VH IVUS system aims to visualize, in a semi-automatic manner, characteristics of the limits and perform spectral analysis of RF ultrasound signals, which the user may wish to follow more closely during routine diagnostic ultrasound imaging exams. The pressure function is designed to be used in all blood vessels, including the coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and / or intervention procedures. The VOLCANO S5I system provides diagnostic information when used in conjunction with catheters deformation of images during VOLCANO formation of ultrasonic images of the peripheral and coronary vasculature. It is intended to be used as an adjunct to conventional angiographic procedures or interventional therapies such as balloon angioplasty.
  • Manufacturer


  • Manufacturer Parent Company (2017)
  • Source